One of the more dangerous companies with a recurrent history of life threatening recalls is now in commissioned by government to make a new vaccine. But can you really trust Baxter to produce a safe flu vaccine? Baxter has a decades-long history of making mistakes that have led to recalls, lawsuits, and even deaths. So what guarantees do we have that they can produce a safe vaccine using a novel method? As recently as May 18 (2009) a Baxter partner, Halozyme Therapeutics, publicly questioned the quality and capabilities of Baxter’s manufacturing processes, when flake-like particles were discovered in a product that Baxter packages for Halozyme. That product, Hylenex, which is used with an injected drug that helps rehydrate sick children, was recalled on May 17 after the contamination was discovered.

This action came only two weeks after the FDA on May 3 announced a recall of Baxter’s Colleague infusion pumps, which deliver fluids such as nutrients and medications into a patient’s body. The recall was listed as Class I, defined as “a situation in which there is a reasonable probability’ that the use of, or exposure to, the product in question “will cause serious adverse health consequences or death.” It was Baxter’s fourth Class I recall this year, and the mainstream press paid very little, if any, attention to them. But the news literally flew around the world May 7, when a jury ordered Baxter to pay $144 million to a Nevada man who contracted hepatitis C from the use of a Baxter product during a routine colonoscopy.

It seems like it wasn’t that long ago when I was writing about another Baxter product that made the news, when Baxter “accidentally” sent vaccines contaminated with LIVE deadly avian (bird) flu to a research facility in Europe. That was February 2009, and the mistake originated in a Baxter plant that was operating under Bio Safety Level 3 (BSL3) status — meaning that high-level precautions are supposed to be in place to make sure an accident like this never happens.

The mistaken shipment was distributed to the Czech Republic, Slovenia and Germany. It was discovered when the Czech laboratory tested the vaccines on ferrets — and the ferrets died, tipping off scientists that the potion was not what it was supposed to be.

Had the error not been discovered, the effects on human lives could have been devastating, because the H5N1 bird flu strain has killed more than 60 percent of the people known to have caught it worldwide. Baxter attributed the mistake to “human error.” Unfortunately, Baxter is no stranger to error.

Baxter Recalls Reflect Repeated Problems

Incredible as it sounds, Baxter has had 40 Class I recalls just since 2003, not counting the four this year. (The FDA’s public records on recalls only go back to 2003; for earlier recalls, you have to file a Freedom of Information Act request). That’s 40 types of recalls that, according to the FDA’s definition, is “a situation in which there is a reasonable probability” that the use of, or exposure to, the product in question “will cause serious adverse health consequences or death.” And that doesn’t include all the Class II recalls Baxter has had through the years, both before and after 2003, as well as a tell-tale list of FDA warning letters that preceded the recalls!

The reasons for the recalls and warnings range from lack of proper documentation on procedures to adulterated products to malfunctioning medical devices. At least one warning — such as this March 25, 2005 letter regarding Baxter’s hemodialysis devices — says that the FDA had received reports of “four deaths which may have been related” to the use of their products. But four deaths is miniscule, compared to this 2001 report, where the FDA said it was investigating over 50 patient deaths worldwide that were linked to Baxter dialyzers.

Other reports refer to Baxter making “false and misleading” statements or labeling, as well as deviations from proper quality controls. Others cite dangerous contamination of products, such as this instance when the FDA discovered syphilis in seven plasma units that Baxter had shipped from its Albany, Georgia, plant. You can find more information on the FDA’s warning letters on Baxter by visiting the FDA’s Electronic Reading Room. Or, you can go here for information on their recalls. But I think you get the picture: Baxter has a long, history of shoddy quality and safety control that, in some instances, not only has harmed people, but has killed them.

Naturally, some of these mistakes have led to lawsuits, such as this one when the National Hemophilia Foundation accused Baxter of knowingly selling AIDS-tainted blood products for use with hemophiliacs in the 1980s and “90s. Probably one of the most notorious lawsuits was filed in 2007 by actor Dennis Quaid and his wife, who believe that the labeling on a blood thinner packaged by Baxter led to the near death of their newborn twins. But, like Henry Chanin, the Quaids are just a few of the many victims of Baxter mistakes.

Now They Want to Give You a ‘Novel’ Flu Vaccine

That’s why I can’t understand why Baxter not only has a contract to create and manufacture a new and very different seasonal and pandemic flu vaccine, but is being paid 100 percent for it by US taxpayers. Yes, Baxter, together with a partner, DynPort Vaccine Co. (DVC) has been receiving federal funds for this influenza vaccine project since May 2006. And, in Baxter’s own words on a press release about this new vaccine, “100 percent of the total of this project’s costs are financed with Federal (United States Government) money!”

This novel vaccine is made with something called Vero cell cultures. What is interesting is that this is the same vaccine that Baxter was developing in Europe, but decided to stop working on in December 2004, when Baxter told the New York Times that it had halted a late-stage clinical trial of a cell culture flu vaccine called PreFluCel because of a higher than expected rate of fever in earlier trial participants.

At the time, Baxter wasn’t sure what was causing these side effects. But the company made a point of defending the Vero cell culture process, saying that “successful vaccines for diseases other than flu were already made by the same process.” While the New York Times doesn’t mention which vaccines those are, I can tell you that one of them is the polio vaccine, which was first made with this process beginning in the 1960s.

Vero Cell Culture Process = Cancer-Causing Monkey Virus

It was almost exactly 10 years ago when the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) reviewed a report on the use of Vero cells, derived from the kidney of an African green monkey,for the production of viral vaccines. Because the Vero cell process enables drug makers to manufacture vaccines much faster than the traditional egg growth medium, several companies were eager to switch to it. The reason for the special meeting was to determine if Vero cell vaccines could be made safely. The reason for the safety issue was because of problems that had come up with the trivalent (three-strain) polio vaccine.

And the problems were serious: Too late — meaning after they had already given this particular polio vaccine to countless numbers of people — scientists discovered that it was possible for unknown, undetectable, cancer-causing viruses to tag along in the Vero cell culture. In this case, it was a cancer-causing type of virus called SV-40, which until the human vaccine was developed, was only found in monkeys.

As it turns out, Vero cells are sensitive to infection with several different types of viruses that are, or could be, made into vaccines, such as measles, rubella, polioviruses, influenza viruses, parainfluenza viruses, respiratory syncytial viruses, and vaccinia (pox viruses). But they also are sensitive to SV-40, an animal carcinogen (cancer-causing) virus.

It took a few years, but SV-40 was later found in people with brain, bone and lung cancers. They were people who had been inoculated with Vero cell culture polio vaccine, a fact that was confirmed by the Institute of Medicine in 2002. You can read more about SV-40 and its cancer-causing potential on the SV-40 Foundation website.

But what is important here is what the scientists said: “The discovery of this new virus, the vacuolating agent, represents the detection for the first time of a hitherto “non-detectable” simian virus of monkey renal cultures and raises the important question of the existence of other such viruses.” Today, SV-40 is listed as a Class 2A human carcinogen.

Here We Go, All Over Again

In its 2000 report on Vero Cell Cultures, the FDA discussed methods that scientists said they could, and would, use to prevent things like this from happening in the future. Ironically, the drug companies’ rationale today for using Vero cells is that this type of technology supposedly provides a cleaner, more pure method of growing vaccine cells than the egg process method. But is that a guarantee, particularly when you’re talking about a pharmaceutical company with such a long history of blunders, mistakes, and documented lack of safety and poor quality control like Baxter’s?

For the answer, we can look at what the Center for Infectious Disease Research and Policy (CIDRAP) said in 2008, when it was reviewing Baxter’s H5N1 bird flu vaccine, Celvapan (which contains the same extremely lethal virus that Baxter “accidentally” shipped out instead of the relatively benign H1N1 virus) … Although CIDRAP hailed Baxter’ H5N1 Vero cell culture process for its ability to boost immune responses with a shorter production time, CIDRAP also said this is “a combination that entails some risk.” And the risk, CIDRAP said, is that “the virus might somehow escape.”

Did they say “escape”, as in perhaps being accidentally shipped in place of another virus that was hardly lethal at all, in comparison? Or was CIDRAP just accidentally being clairvoyant, seeing how that’s exactly what happened? I won’t belabor the point by reminding you that, mistakes aside, Baxter will soon be asking you to trust it with its latest Vero cell culture vaccines for seasonal and H1N1 flu. But some questions still remain: First, did Baxter figure out what was causing the unusually high fevers in its European version of its new vaccine? Or did the company just forge ahead in the US, without addressing those issues?

And second, given Baxter’s repetitive, blundering history with FDA recalls alone, just what assurance do you have that, even if Baxter has addressed the higher-than-expected side effects issues, that they aren’t still going to be a problem? The answer is, you don’t have any assurance. All you have, really, are the examples that Baxter has already set. And you now have a better idea of what they are.

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